7-Ketolithocholic Acid in Prediabetes
ConditionPre-diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorICE S.p.A.
About this trial
7-Ketolithocholic Acid, a naturally occurring bile acid, is a novel food currently under investigation for potential metabolic benefits, including glucose-lowering effects. This study aims to evaluate the efficacy and safety of 7-Ketolithocholic Acid, administered alongside a low-glycaemic, hypocaloric diet, and increased physical activity in reducing fasting plasma glucose and other metabolic parameters in subjects with prediabetes. Demonstrating a clinically meaningful glucose-lowering effect would support its potential role in early intervention to prevent or delay the onset of type 2 diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female participants aged ≥18 years and ≤70 years.
Ability and willingness to provide written informed consent.
Impaired fasting glucose (IFG): fasting plasma glucose levels between 100 and 125 mg/dL.
Impaired glucose tolerance (IGT): plasma glucose levels between 140 and 199 mg/dL measured 2 hours after a standard oral glucose tolerance test (OGTT).
Disqualifiers
Previous or current diagnosis of diabetes mellitus.
Presence of hypertension, defined as blood pressure >130/85 mmHg.
Hypertriglyceridemia, defined as fasting blood triglyceride levels ≥ 200 mg/dL.
LDL cholesterol ≥ 190 mg/dL.
Trial design
Design model
Parallel
Treatments tested in this trial
7-KLCA
Dietary supplementThis is a prospective, randomized, double blind, multicenter study. Subjects will be randomized in a 1:1 ratio; each subject will be included into one of the two intervention groups. Each subject will attend 6 visits in total Visit 1: Day -7 (Screening, Informed consent signature, sampling for laboratory tests) Visit 2: Day 0 (Eligibility assessment, enrolment, randomization, drug dispense; diary dispense) Visit 3: Week +4 (Telephone call, diary verification) Visit 4: Week +8 (same as Visit 3) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit. Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity.
Placebo
Dietary supplementThis is a prospective, randomized, double blind, multicenter study. Subjects will be randomized in a 1:1 ratio; each subject will be included into one of the two intervention groups. Each subject will attend 6 visits in total Visit 1: Day -7 (Screening, Informed consent signature, sampling for laboratory tests) Visit 2: Day 0 (Eligibility assessment, enrolment, randomization, drug dispense; diary dispense) Visit 3: Week +4 (Telephone call, diary verification) Visit 4: Week +8 (same as Visit 3) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit. Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity.
Diet and Physical Activity
Other interventionThe dietary intervention in this study involves a low-glycaemic, hypocaloric diet, aimed at improving glycaemic control, reducing fasting plasma glucose, and supporting weight management, based on official recommendations from authoritative bodies such as the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Physical activity is a cornerstone of lifestyle intervention in prediabetes. It improves insulin sensitivity, glucose metabolism, and cardiovascular risk factors, and facilitates weight management \[2,24\]. Combining physical activity with dietary modifications enhances prevention of progression to type 2 diabetes. All of the following will be recommended: aerobic exercise, resistance training, reducing sedentary time, flexibility and balance exercises.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: 7-KLCAActive comparator 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Mean change in Fasting Plasma Glucose (FPG)
Difference in the mean change in fasting plasma glucose (FPG) from baseline to Week 12 between the treatment and placebo groups.
Time frame
Baseline and Week 12Secondary outcomes
1
Difference in mean changes in HbA1c, cholesterol, LDL, HDL, body weight and/or BMI, waist circumference, 2 hr oral glucose tolerance test.
To observe the effects of 7-Ketolithocholic Acid associated with diet and physical activity on glycaemic metabolism, lipid profile and BMI/waist circumference.
Time frame
Baseline and Week 12Other outcomes
1
Assessment of overall safety and tolerability of 7-KLCA (400mg) administered for 12 weeks.
Number and description of Adverse Events and Serious Adverse Events (including laboratory changes) in the two groups of treatment (7-Ketolithocholic Acid 400 mg and placebo administered for 12 weeks).
Time frame
Throughout the course of the study period (12 weeks). Source ClinicalTrials.gov